Quality Assurance

Quality Assurance

Quality Assurance

Our injection moulded parts’ validation process evolved through our work with automotive OEMs. As a result, it reaches beyond the requirement of most other industries, but offers the reassurance of stringent quality protocols and a process that can be tailored to suit your component. We have found this method particularly useful for medical manufacturing.

During the Design for Manufacture stage of a project, a risk assessment of the product is performed and the outcome of this is formulated into an FMEA Process Flow flowchart, which will identify all potential failures in the design, manufacturing or assembly process.  Our objective is to eliminate these risks before production commences.

When the FMEA is complete, we develop bespoke test and gauge methods that will mimic the component’s intended use and/or assembly interfaces.  These tools are used by our quality engineers on the shop floor and our Metrology Department to check parts in the new project validation stage, and subsequently, each time they run in production.

White Horse Plastics ISO 9001

UK Manufacturing

The industry standard for business management systems.

White Horse Plastics ISO 13485

Medical Manufacturing

The specific standard for medical devices. Highlighting traceability and cleanliness requirements.

White Horse Plastics IATF 16949

Automotive Manufacturing

The standard covers Quality Control Planning, Failure Mode and Effects Analysis (FMEA), Statistical Quality Control and Measurement System Analysis.

White Horse Plastics ISO 14001

Environmental Impact

The industry standard with a series of requirements enabling an organisation to control its impact on the environment.

In addition to our ISO & IATF Accreditations, we are members of the AIAG (Automotive Industry Action Group). They are a not-for-profit consisting of automotive professionals who work collaboratively to streamline industry processes via global standards development & harmonised practices.

Our membership enables us to use the well regarded AIAG tools and resources to improve our own QMS, thus providing a better service to our clients.

If you’d like to find out more about our validation processes, please review the below:

PPAP - Production Part Approval Process

The Production Part Approval Process (PPAP) is a series of documents gathered by suppliers for the formal certification/sign-off of a new or modified component.  The process was developed by AIAG (The Automotive Industry Action Group) and is used in the automotive and aerospace industries to ensure a standardised validation process is followed.  It enables clear communication of customer objectives, such as critical dimensions and production schedules, and documents all elements of the manufacturing process for that part, including provenance of materials and in-production, quality assurance processes.

The PPAP can be tailored for the manufacture of components in other sectors, to establish stable manufacturing processes that adhere to recognised standards, such as for the production of medical devices.

Cpk - Process Capability

The Process Capability Index (Cpk) is a statistical tool that measures the ability of a process to produce output within a customer specification limit.  A score of <1.0 is ranked as poor or incapable; a score of > 1.67 is assessed as capable and a score of 2.0 or higher is assessed as excellent, and compliant with 6 Sigma manufacturing environments.

White Horse Plastics frequently maintains Cpk scores of 2.0 or higher.

FMEA - Failure Mode & Effects Analysis

FMEA is a process analysis tool - a structured approach to identifying all possible failures in a design, manufacturing or assembly process.  It is conducted at White Horse Plastics by a cross functional team representing all stages of a new part's process in advance and in the early stages of its Design for Manufacture.  Potential risks are documented and solutions devised in the form of process flow charts, which are referred to for best practise during the life time of the component.

R&R - Repeatability & Reproducibility

Repeatability and reproducibility studies confirm the methods of product measurement, including the calibration of all measuring equipment.  When these measurement systems have been determined, statistical analysis and Cpk are implemented.  Statistical studies map the entire process together with any possible process variations.

WHP deploys a wide range of testing and measuring equipment for these processes including CMM, an optical and tensile testing machine, practical height gauges, comparators and other hand held devices.

Final checks at WHP ensure that all product labels and packaging are correct, traceability can be provided and use of batch numbers, bar codes and unique box identification provides confidence of receipt of the correct product at the right time.

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